Device for closure of a vascular defect and method for treating the same

ABSTRACT

A device for the non-invasive treatment of a vascular defect. The device includes at least one occlusive member having a first unexpanded configuration and a second expanded configuration and at least one securement member for securing the vaso-occlusive device to a support structure at the location of the vascular defect.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/230,803, filed Aug. 29, 2002, now abandoned the entire content ofwhich is incorporated by reference

FIELD OF THE INVENTION

The present invention relates generally to implantable devices andmethods for the treatment of vascular defects.

BACKGROUND OF THE INVENTION

Many minimally invasive or noninvasive interventional medical devicesand procedures have been used to treat defects in the vasculature whichare not easily reached by surgical procedures. Such medical deviceswhich are adapted for implantation in body lumens in order to supportweakened or occluded vessel walls and allow fluid flow are well knownand commercially available. One such device is a vascular stent, forexample. Stents may be employed to prop up vessel walls and maintainopenings in vessels in the coronary system, the brain, the urinary,biliary, esophageal, tracheal and bronchial tracts, and so forth.

However, in some situations, it is desirable to block fluid flow. Forexample, one serious defect in the vascular system is an aneurysm whichis an area of a weakened vessel wall that causes a bulge or bubble toprotrude out in a radial direction from the adjacent vessel. Ifuntreated, an aneurysm may continue expanding until it bursts, causinghemorrhage. It is therefore often desirable to block fluid flow to theaneurysm.

Devices used for the treatment of such defects may be referred to asvaso-occlusive devices and are commonly deployed to the aneurysm sitethrough the use of a catheter device. Vaso-occlusive devices can have avariety of configurations, and are generally formed of one or moreelements that have a deployed configuration for blocking blood flowwhich is different from their configuration during delivery to the site.

Devices for bridging the necks of wide-necked or narrow-necked aneurysmsare found, for example, in U.S. Pat. No. 5,935,148, U.S. Pat. No.6,063,070, U.S. Pat. No. 6,036,720, U.S. Pat. No. 6,063,104 and U.S.Pat. No. 6,139,564. These devices may also be used to stabilize theplacement of vaso-occlusive devices such as helically wound coils in theaneurysm or may be used to, at least partially, close the aneurysm neck.The aneurysm neck bridge or retainer assemblies described in the patentsabove may be delivered to the aneurysm in a variety of different ways,but preferably are attached to an electrolytically severable joint fortheir deployment. After deployment of the neck bridge or retainer, theaneurysm is at least partially filled with a vaso-occlusive device suchas a helically wound coil. The vaso-occlusive devices may also bedelivered to the aneurysm using a number of different methods such as bya core wire which is linked to the coils by an electrolyticallyseverable joint or a mechanically severable joint. The vaso-occlusivedevices may also be simply pushed into the aneurysm. The success of suchdevices as those described above, may depend on several factors,however, including whether or not the device can migrate out of theaneurysm through the neck of the aneurysm.

Another example of a vaso-occlusive device applicable to the treatmentof an aneurysm is a covered stent or a stent-graft. Covered stents havea limited usefulness due to the stiffness of the device, and syntheticgrafts themselves have a tendency to occlude when employed in smallblood vessels. Arteries where there is an aneurysm typically have a lotof branching, and when employing a covered stent, there is a furtherrisk of occluding the small branch vessels airising from the parentartery rather than simply blocking the neck of the aneurysm as desired.

Thus, it would be beneficial to have a vaso-occlusive device that can bedelivered to an aneurysm or other body vessel in a primary unexpandedconfiguration, wherein such device can be deployed and released toassume a secondary, expanded configuration which occludes the neck ofthe aneurysm, and which can be anchored at the site of the aneurysm sothat it does not migrate from the site.

SUMMARY OF THE INVENTION

The present invention relates generally to a vaso-occlusive device whichis adapted to be inserted into a portion of a vasculature for treatmentof a body vessel such as an aneurysm, and to methods of using thedevice. The vaso-occlusive device of the present invention is generallyemployed in combination with a support structure such as a stent,stent-graft, and the like. The device is designed in such a way that itmay be readily anchored at the site of the vascular defect to preventmigration of the device. Of course, more than one support structure maybe employed in a given procedure as well.

The vaso-occlusive device of the present invention includes at least oneocclusive member having a first unexpanded configuration and a secondexpanded configuration, and at least one securement member for securingthe device to a stent, stent-graft, or the like, in order to preventmigration of the fluid flow-occluding device from the site of thevascular defect.

The device is retained within or as a part of a microcatheter system inan unexpanded configuration to cross the neck of the aneurysm, and thenonce across the neck, the device may be allowed to expand by pullingback the microcatheter, pulling back a shaft about the microcatheter, orby employing a pusher device.

The device may be formed of a variety of materials including, but notlimited to flexible polymeric materials and metallic materials includingshape memory materials, superelastic materials, compressed foams,swellable materials, braided or woven materials and meshes formed fromboth polymeric materials and shape memory alloys, for example, and soforth. Suitably, the materials are biocompatible.

Bioactive materials or materials having incorporated bioactive agentsmay also be employed in the construction of the device according to thepresent invention.

The device may be employed in minimally invasive, interventionalprocedures for the treatment of a vascular defect where it is desirableto block the flow of fluid, if not completely then to a substantialdegree, into the defective area of the vessel.

In one embodiment, the method includes deploying a support structure tothe site of the vascular defect, deploying the vaso-occlusive device tothe site of the vascular defect, inserting the vaso-occlusive deviceinto the vascular defect through an opening in the support structure,deploying at least one occlusive member, and deploying at least onesecurement member.

Suitably, both the support structure and the vaso-occlusive device aredeployed using a catheter.

These and other aspects and advantages of the invention will becomeapparent from the following detailed description and the accompanyingdrawings, which illustrate by way of example the features of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a vaso-occlusive device accordingto the present invention.

FIG. 2 is a depiction of a stent located in a blood vessel at the siteof an aneurysm prior to deployment of a vaso-occlusive device accordingto the present invention.

FIG. 3 illustrates initial delivery of a catheter device with thevaso-occlusive device of the present invention retained therein.

FIG. 4 illustrates initial deployment of the vaso-occlusive devicereleased from the catheter but in an unexpanded state.

FIG. 5 illustrates one embodiment of the occlusive member of thevaso-occlusive device of the present invention in an expanded state.

FIG. 6 illustrates one embodiment of the vaso-occlusive device of thepresent invention positioned at the neck of an aneurysm.

FIG. 7 illustrates one embodiment of the vaso-occlusive device of thepresent invention in an expanded state with the securement memberreleased and in position.

FIG. 8 illustrates a vaso-occlusive device according to the presentinvention, in combination with a catheter delivery device.

FIG. 9 illustrates the device of FIG. 8 during deployment.

FIG. 10 illustrates the vaso-occlusive device of FIG. 8 afterdeployment.

FIG. 11 is an expanded view of one embodiment of the securement memberprior to deployment.

FIG. 12 is an expanded view of the same securement member as in FIG. 11but in a deployed configuration.

FIG. 13 illustrates an alternative embodiment of the securement memberof the vaso-occlusive device of the present invention prior to releasefrom the catheter.

FIG. 14 illustrates the same securement member as shown in FIG. 13, butafter release from the catheter.

FIG. 15 illustrates another alternative embodiment wherein both theocclusive member and the securement member are formed of the samematerial.

FIG. 16 illustrates the same device as shown in FIG. 15 with both theocclusive member and the securement member deployed.

FIG. 17 illustrates a specialized opening which may be formed in a stentfor accepting the vaso-occlusive device.

DETAILED DESCRIPTIONS OF THE PREFERRED EMBODIMENTS

While this invention may be embodied in many different forms, there aredescribed in detail herein specific embodiments of the invention. Thisdescription is an exemplification of the principles of the invention andis not intended to limit the invention to the particular embodimentsillustrated.

Turning now to the figures, FIG. 1 illustrates generally at 100, oneembodiment of the vaso-occlusive device according to the presentinvention in which the occlusive member 20 is in a fully expanded form,but the securement member 30 has not yet been released from the catheter50. The top of the securement member 30 is visible. A pusher wire 22 isshown disposed within the catheter lumen.

Also seen in FIG. 1 is a severable junction 40 for severing theconnection between a catheter delivery device 50 and the vaso-occlusivedevice 100 after deployment of vaso-occlusive device 100. Junction 40may be severed using any of a variety of different methods including,but not limited to, electrolytic corrosion, mechanical actuation,hydraulic pressure, thermal processes, electromagnetic energy, and soforth as described above. Other methods of detachment known to those ofskill in the art but not described herein may also be employed inreleasing the device of the present invention. Severable junctions whichmay be employed in the present invention are described, for example, inU.S. Pat. No. 5,122,136, U.S. Pat. No. 5,354,295, U.S. Pat. No.5,540,680, U.S. Pat. No. 5,855,578, U.S. Pat. No. 5,895,385, U.S. Pat.No. 5,925,037, U.S. Pat. No. 5,944,714, U.S. Pat. No. 5,947,963, U.S.Pat. No. 5,976,126, U.S. Pat. No. 6,010,498, U.S. Pat. No. 6,066,133 andU.S. Pat. No. 6,083,220, each of which is incorporated by referenceherein in its entirety.

FIGS. 2-7 illustrate a series of steps involved in the deployment of thevaso-occlusive device 100 according to the present invention. Beginningwith FIG. 2, a support structure, in this embodiment a stent 10, isshown deployed within a blood vessel 12 at the site of a vessel defector aneurysm 14 and located at the opening or neck 19 of the aneurysm 14.The stent 10 has a plurality of stent struts 15 having openings 17therebetween. Stent 10 is in its expanded configuration within bloodvessel 12. An occlusive device according to the present invention may beformed and configured such that it may be deployed through the openings17 between struts 15.

While the above stent is shown for illustrative purposes only, it isimportant to note that any stent design may be employed herein.

FIG. 3 illustrates the initial delivery of one embodiment of the deviceof the present invention (not visible in FIG. 2) in an unexpanded statethrough the use of a microcatheter device 50, such as a microcatheter.The microcatheter 50 is guided through blood vessel 12 and through stent10 and is then threaded through an opening 17 located between stentstruts 15 and into the aneurysm 14. The vaso-occlusive device 10 (notshown) may be rolled, compressed or otherwise unexpanded into a formthat can be pushed through and retained in microcatheter 50. In FIG. 4,the microcatheter 50 can be seen shown disposed within stent 10 in bloodvessel 12 and projecting upward through opening 17 formed by struts 15and into aneurysm 14. The securement member 30 can be seen at the distaltip 55 of microcatheter 50.

In FIG. 4, vaso-occlusive device 100 is shown in the initial stage ofbeing released from microcatheter 50 by use of a pusher wire 22 (notshown). The occlusive member 20 is still in an unexpanded configuration.The securement member 30 is also in its unexpanded configuration.Reference numeral 40 represents a detachable or severable junction whichcan be severed using a number of different mechanisms including, but notlimited to, electrolytic corrosion, mechanical actuation, hydraulicpressure, thermal processes, electromagnetic energy, and so forth asdescribed above. It is at this junction 40 that the vaso-occlusivedevice 100 is eventually detached from pusher wire 22 (not shown) whichis disposed inside microcatheter 50. Other methods of detachment notdescribed herein, but known in the art, may also be employed indetaching the device of the present invention.

As noted above, severable junctions are described, for example, in U.S.Pat. No. 5,122,136, U.S. Pat. No. 5,354,295, U.S. Pat. No. 5,540,680,U.S. Pat. No. 5,855,578, U.S. Pat. No. 5,895,385, U.S. Pat. No.5,925,037, U.S. Pat. No. 5,944,714, U.S. Pat. No. 5,947,963, U.S. Pat.No. 5,976,126, U.S. Pat. No. 6,010,498, U.S. Pat. No. 6,066,133 and U.S.Pat. No. 6,083,220, each of which is incorporated by reference herein inits entirety.

Upon release from microcatheter 50, occlusive member 20 expands as shownin FIG. 5. Occlusive member 20 may be made expandable upon release usingany number of methods known in the art. For example, shape memorymaterials including both polymeric and metallic materials may beemployed, materials which are swellable in an aqueous environment may beemployed, compressed foams, braided, woven, knit, felt-like materials,meshes, and so forth, may also be employed. In this particularembodiment, occlusive member 20 is shown in an umbrella-like form.However, occlusive member 20 may be in the form of a disc, parabola,sphere, or the like providing that it is of a configuration to block orbridge the neck 19 of aneurysm 14 so that no fluid, or substantially nofluid, may flow between vessel 12 and aneurysm 14. Suitable materialsfor formation of such an occlusive member include flexible polymericmaterials, for example. Securement member 30, is also not yet in itsdeployed configuration.

Occlusive member 20 is then pulled back until it comes in contact withstent 10 and is now blocking the opening or neck 19 of aneurysm 14 asshown in FIG. 6. At this point, securement member 30, is at leastpartially protruding through the opposite side of the stent struts 15 asthe occlusive member 20, and is still in an unexpanded configuration.

The securement member 30 is then released by pulling back on thecatheter device 50 while maintaining the position of the pusher wire 22as shown in FIG. 7. The securement member 30 upon release from thecatheter device 50 expands. In its expanded configuration, securementmember 30 anchors the vaso-occlusive device 100 to the stent 10. Thesecurement member 30 is located on the opposite side of the stent struts15 as the occlusive member 20. Securement member 30 may operate in oneof several different ways. Desirably, the securement member 30 operatesby either expanding to the point at which it may no longer fit backthrough the opening 17 between stent struts 15 through which itinitially came, or it may be constructed of a shape memory material, forexample, that remains inside the microcatheter 50 until deployment ofthe occlusive member 20. Thus, it does not deploy until the occlusivemember 20 is deployed.

In FIG. 7, the microcatheter 50 is shown being drawn away from thevaso-occlusive device, releasing the securement member 30 which thenlays open and flat against the stent struts 15. The securement member 30extends through and is located on the opposite side of the occlusivemember 20 and effectively anchors the vaso-occlusive device 100 intoposition.

FIG. 8 illustrates generally at 110 a catheter delivery device having avaso-occlusive device 100 disposed inside a retractable sheath 116 atthe distal end 112 of the catheter delivery device 110. The catheterdevice has a tubular support structure 114. In this embodiment, aguidewire 75 is first positioned inside the vasculature. The catheterdelivery device 110 is then maneuvered through the vasculature over theguidewire 75 to the site of the vascular defect (not shown) wherein asupport structure such as a stent, has already been positioned. Thecatheter delivery device 110 is then maneuvered between struts 15 of thestent structure and is positioned in the vascular defect (not shown). InFIG. 8, the catheter delivery device 110 is shown positioned between twostruts 15. The vaso-occlusive device is not yet deployed.

In FIG. 9, the retractable sheath 116 is shown in a partially pulledback position releasing the occlusive member 20 of the vaso-occlusivedevice 100.

In FIG. 10, the retractable sheath 116 has been pulled back all the wayfurther releasing the securement member 30 of the vaso-occlusive device100.

The vaso-occlusive device 100 as shown in FIGS. 8-10, illustrates anembodiment of the vaso-occlusive device in which the occlusive member 20has a frame 118 which in its unexpanded state as shown in FIG. 8 and inan expanded state as shown in FIG. 10, is similar to an umbrella. Theframe 118 has individual spokes 120 which in the expanded state supportthe canopy 122 of the umbrella-like structure.

FIG. 11 illustrates one embodiment of the securement member 30 of thevaso-occlusive device of the present invention in which securementmember 30 is formed from a swellable material such as a hydrogel whichswells upon exposure to an aqueous environment, or one with memory suchas a compressed foam wherein the material returns to its original shapeupon release from the microcatheter 50. In FIG. 11, securement member 30is shown just released from microcatheter 50 and is not yet in itsexpanded configuration. Struts 15 are shown on either side of thesecurement member 30. FIG. 12 illustrates the same securement member 30as in FIG. 11, but in a deployed configuration. Struts 15, are nowlocated between occlusive member 20, which is now in an expandedconfiguration, and securement member 30, which is also in a deployedconfiguration. FIG. 12 shows the securement member 30 wherein it isanchored to the stent by “wrapping” itself around the stents struts 15in its deployed state. Occlusive member 20, may also be formed from thesame swellable material, or the same material having memory assecurement member 30. It may also be formed of a different material.

FIG. 13 illustrates an alternative embodiment of the vaso-occlusivedevice of the present invention in which the securement member 30 isformed from strut-like elements 60 which are held inside microcatheter50. The struts 15 may be leaf shaped (as shown) on a flattened helicalform, or may be any shape which can be compressed to fit within amicrocatheter and can expand to a shape which cannot fit through theopenings in the strut 15. When microcatheter 50 is pulled back fromstent 10, the strut-like elements 60, are released and open, laying flatagainst stent struts 15 as shown in FIG. 14. In this embodiment,strut-like elements 60 of securement member 30, may be formed of a shapememory material such as NITINOL®, or may be formed from a superelasticmaterial.

Also visible in FIG. 14, is a severable junction 40 which is describedabove. Severable junction 40, in this embodiment, is shown in contactwith occlusive member 20, as opposed to the embodiment shown in FIGS. 11and 12, in which severable junction 40, is shown in contact withsecurement member 30.

FIG. 15 illustrates an embodiment of the vaso-occlusive device of thepresent invention in which both the occlusive member 20 and thesecurement member 30 are formed from a single material. In thisembodiment, a material which swells upon exposure to an aqueousenvironment. Such materials include, for example, hydrogels, compressedfoams, or the like. Swellable materials are discussed in more detailbelow. As shown in FIG. 15, both the occlusive member 20 and thesecurement member 30 have been released using the pusher wire, and theybegin to swell. The vaso-occlusive device 100 is then brought down intothe neck of the aneurysm such that the securement member 30 is on theopposite side of the stent struts 15 from the occlusive member 20. Theswelling continues and the device blocks the aneurysm. The device is inits fully expanded configuration in FIG. 16. As can be seen from FIG.16, the securement member 30 is on one side of the struts 15 and theocclusive member 20 is on the opposite side and actually in the aneurysm(not shown). In this manner, the securement member 30 anchors thevaso-occlusive device 100 to the stent.

In another embodiment, rather than deploying the vaso-occlusive device100 (only shown in partial view) through openings formed between stentstruts, the stent may be made with a specialized opening 70 foraccepting the vaso-occlusive device 100 of the present invention asshown in FIG. 17.

Again, in FIGS. 15-17, a severable junction 40 is shown for detachingvaso-occlusive device 100 from catheter delivery device 50.

While in the embodiments described above, only one securement member hasbeen employed in each embodiment, one or more securement members may beemployed in the present invention. Securement members of any shape maybe employed.

Further, support structures of any shape may be employed. For example,linear, Y-shaped, T-shaped stents, and so forth may be employed.

The occlusive portion of the device according to the present inventionmay be manufactured from any of a variety of materials including, butnot limited to, polymeric materials. Examples of useful polymericmaterials include both synthetic and natural materials. Further, thematerials may be biocompatible and/or biodegradable materials. Examplesof useful polymer materials include, but are not limited to, polyolefinsincluding polyethylene and polypropylene, polyesters such aspolyethyleneterephthalate (PET) and polybutylene terephthalate (PBT),polyurethanes, acrylics, polypeptides, polyethers, polyamides,fluoropolymers such as expanded polytetrafluoroethylene, and so on andso forth.

Swellable polymeric materials find utility herein. Such materialsinclude those which are known to expand and become lubricious in aqueousfluids including, for example, a class of materials referred togenerally as hydrogels may also be employed in the manufacture of thedevice according to the present invention. Such materials includehydrophilic, macroporous, polymeric, hydrogel foam material. Examples ofsuch materials include, but are not limited, polyvinylpyrrolindone,polyethylene oxide and its copolymers with polypropylene oxide,polyacrylic acids, polyvinyl alcohols, hyaluronic acid, heparin,chondroitin sulfate, pectinic acid, carboxyl-derivatizedpolysaccharides, polyhydroxy ethyl methacrylate, polyacrylamide,hydrolyzed polyacrylonitriles, polymethacrylic acid, polyethyleneamines, polysaccharides, and copolymers and combinations thereof, and soforth.

One particular example of a swellable material includes a swellable foammatrix formed as a macroporous solid is described in U.S. Pat. No.5,750,585 which is incorporated by reference herein in its entirety.This material includes a foam stabilizing agent and a polymer orcopolymer of a free radical polymerizable hydrophilic olefin monomercross-linked with up to about 10% by weight of a multiolefin-functionalcross-linking agent.

Naturally based materials or those which are biologically derived whichfind utility herein include, but are not limited to, collagen foams,harvested vascular material, films constructed from processed tissues,and so forth.

Shape memory materials are suitable for use in formation of thevaso-occlusive device of the present invention. Shape memory materialsmay be polymeric or metallic. Shape memory materials have the ability toremember their original shape, either after mechanical deformation, orby cooling and heating. Such materials are said to undergo a structuralphase transformation. Typically, shape memory polymers (SMPs) are foundto be segregated linear block co-polymers having a hard segment and asoft segment wherein the hard segment is crystalline, with a definedmelting point, and the soft segment is amorphous, with a defined glasstransition temperature. However, the hard segment may be amorphous andhave a glass transition temperature rather than a melting point, and thesoft segment may be crystalline and have a melting point rather than aglass transition temperature. The melting point or glass transitiontemperature of the soft segment is substantially less than the meltingpoint or glass transition temperature of the hard segment. Some examplesof shape memory polymers include, but are not limited to, those formedfrom polyethers, polyacrylates, polyamides, polysiloxanes,polyurethanes, polyether amides, polyurethane/ureas, polyether esters,urethane/butadiene copolymers, polynorbornenes, and mixtures thereof.See, for example, U.S. Pat. No. 5,506,300, U.S. Pat. No. 5,145,935, U.S.Pat. No. 5,665,822, and U.S. Pat. No. 6,388,043 each of which isincorporated by reference herein in its entirety.

Shape memory metals suitable for use herein include the alloys of TiNi(NITINOL®), CuZnAl, and FeNiAl, for example. These materials undergo astructure phase transformation referred to as a martensitictransformation.

Compressed foams may also be employed in the present invention becausethey have the ability to return to their original shape. Both open andclosed cell foams may be employed. Materials satisfactory for use incompressed foams include, but are not limited to medical grade siliconesand polyurethanes. As described above, natural materials such ascollagens, may also be employed to make a compressed foam material.

Bioactive materials or materials having incorporated bioactive agentswhich facilitate aneurysm healing may also be employed in theconstruction of the device. Bioactive materials include agents whichillicit a biological response within a patient. Such bioactive includetherapeutic agents and drugs, for example. These agents may promotehealing, tissue growth, cell growth, and so forth.

The vaso-occlusive device, in particular, the occlusive member, may beformed with a braided, woven, or mesh configuration.

Copolymers, and crosslinkable versions of the above described materialsmay also be suitable for use herein. And, of course, mixtures of thevarious materials described above may also be employed in themanufacture of the device according to the present invention.

A single material may be employed in forming both the occlusive memberand the securement member, or different materials may be employed asdescribed in some of the embodiments above. Additionally, one or morematerials may be employed in forming only the occlusive member and/orthe securement member. For example, in a further embodiment, theocclusive member may be formed of a combination of at least onepolymeric material and at least one metal. In this embodiment, ametallic material such as a shape memory alloy, is employed to form thestrut parts of an umbrella like structure which has an occlusive membersimilar to the canopy of an umbrella, and further has a frame includinga plurality of spokes for providing support to the canopy. The canopy isformed of a polymeric material while the frame may be formed a metallicmaterial or a polymeric material, for example. The frame and canopy havean expanded configuration and an unexpanded configuration for delivery.

The above lists of materials are intended for illustrative purposes onlyand are by no means exhaustive. One of ordinary skill in the art knowsmaterials of the types described above.

The material from which the vaso-occlusive device is formed, or thevaso-occlusive device itself may be modified, or provided withadditives, to make the vaso-occlusive device visible by conventionalimaging techniques. For example, the device may be rendered visibleusing fluoroscopic techniques, rendered MRI visible, or both. This canbe accomplished through the use of markers such as wire windings, markerbands, rivets, plugs, and so forth, or the radiopaque or MRI visiblematerials may be incorporated into the material from which thevaso-occlusive device is formed. Any suitable radiopaque or MRI visiblematerial may be employed.

Suitable materials for providing radiopacity to the device include, butare not limited to, platinum, rhodium, palladium, rhenium, iridium,tantalum, tungsten, gold, silver, alloys of these metals, as well aspolymeric materials with barium, for example. Radiopacity is desirablefor visualization of the device for purposes of positioning the deviceat the site of the defect and to position inside the defect and forproper anchoring of the device.

The invention is further directed to the combination of a vaso-occlusivedevice having at least one securement member and a stent, where the atleast one securement member is secured to the stent. Also, the inventionis directed to the combination of a delivery catheter and avaso-occlusive device having at least one securement member.

The invention is further directed to a method of occluding a vasculardefect having an opening. The method comprises the steps of:

-   -   a) deploying a support structure, as discussed above, to the        vascular defect, the support structure having an opening for        accepting a vaso-occlusive device;    -   b) deploying a vaso-occlusive device having at least one        occlusive member having an expanded configuration and an        unexpanded configuration, as discussed above and at least one        securement member, as discussed above, through the opening of        the support structure and through the opening of the vascular        defect into the vascular defect;    -   c) expanding the at least one occlusive member; and    -   d) anchoring the vaso-occlusive device to the support structure        with the at least one securement member.

The invention is also directed to a method of closing and occluding anopening of an aneurysm from a parent blood vessel. The method comprisesthe steps of:

-   -   a) deploying a support structure, as discussed above, at the        site of the aneurysm, the support structure having at least one        opening for accepting a vaso-occlusive device as discussed        above, the vaso-occlusive device having at least one occlusive        member which has an unexpanded configuration and an expanded        configuration and at least one securement member, the support        structure positioned at the opening of the aneurysm such that        the at least one opening of the support structure is aligned        with the opening of the aneurysm;    -   b) deploying the vaso-occlusive device wherein the at least one        occlusive member is in its unexpanded configuration, through the        at least one opening of the support structure and the opening of        the aneurysm and into the aneurysm;    -   c) expanding the at least one occlusive member of the        vaso-occlusive device to its expanded state whereby the        vaso-occlusive device blocks the opening of the aneurysm from        the parent blood vessel in its expanded state; and    -   d) anchoring the vaso-occlusive device to the support structure        with the at least one securement member.

The above disclosure is intended for illustrative purposes only and isnot exhaustive. The embodiments described therein will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

The invention claimed is:
 1. A vaso-occlusive assembly, comprising: astent defining an interior region and configured to be implanted in ablood vessel lumen across a neck opening of a vascular defect, and atleast one occlusive member connected to at least one proximallyextending securement member across a wall of the stent, wherein the atleast one occlusive member and the at least one securement member aresized and shaped such that the at least one occlusive member and the atleast one securement member are secured to the stent with the at leastone occlusive member located outside of the stent interior region andthe at least one securement member located within the stent interiorregion, wherein the at least one occlusive member is configured forinsertion into the vascular defect by introduction through the interiorregion of the stent, exiting the stent between respective strutsthereof, into the vascular defect, and wherein said at least oneocclusive member of said vaso-occlusive device is in the shape of anumbrella-like canopy, parabola, or sphere wherein the at least oneproximally extending securement member is configured to engage therespective stent struts as the occlusive member enters the vasculardefect.
 2. An assembly for the treatment of a vascular defect, saidassembly comprising: a support structure defining an interior region andconfigured to be positioned transversely to a neck of the vasculardefect; and at least one occlusive member connected to at least onesecurement member across a wall of the support structure, wherein the atleast one occlusive member and the at least one securement member aresized and shaped such that the at least one occlusive member and the atleast one securement member are secured to the support structure withthe at least one occlusive member outside of the support structureinterior region and the at least one securement member inside thesupport structure interior region, wherein the at least one occlusivemember comprises an umbrella-like canopy, a parabola, or a sphereconfiguration having a continuous surface configured to bridge the neckof the vascular defect and substantially block the flow of fluid to saiddefect, and wherein the at least one securement member is configured toengage the support structure.
 3. The assembly of claim 2, wherein saidsupport structure is a stent or stent/graft.
 4. The assembly of claim 3,wherein said support structure is a stent of the self-expanding variety.5. The assembly of claim 2, wherein said at least one securement member,said at least one occlusive member, or both, are comprised of a metal ormetal alloy.
 6. The assembly of claim 5, wherein said metal is a shapememory metal.
 7. The assembly of claim 2, wherein said at least oneocclusive member, said at least one securement member, or both, areformed from a polymeric material.
 8. The assembly of claim 7, whereinsaid polymeric material is selected from the group consisting ofpolyurethanes, polyolefins, polyesters, polyamides, fluoropolymers,silicones, acrylics, polypeptides, and mixtures thereof.
 9. The assemblyof claim 7, wherein said polymeric material is a swellable polymericmaterial which swells in an aqueous environment.
 10. The assembly ofclaim 9, wherein said swellable polymeric material is a hydrogel. 11.The assembly of claim 2, wherein said at least one occlusive member, atleast one securement member, or both, are formed from a biologicallyderived material.
 12. The assembly of claim 11, wherein saidbiologically derived material is selected from the group consisting ofcollagen foams, harvested vascular material, processed tissues andcombinations thereof.
 13. The assembly of claim 2, wherein said at leastone occlusive member is formed from a combination of at least onepolymeric material and at least one metal or metal alloy.
 14. Theassembly of claim 2, wherein said at least one occlusive member and saidat least one securement member are formed from a compressed foam. 15.The assembly of claim 2, wherein at least a portion of said at least oneocclusive member has a braided, woven, knit, felt-like or meshconfiguration.
 16. The assembly of claim 2, further in combination witha catheter.
 17. The assembly of claim 2, further comprising at least oneradiopaque material.
 18. The assembly of claim 2, further comprising atleast one bioactive material.
 19. A vaso-occlusive assembly, comprising:a stent defining an interior region and configured to be positionedtransversely to a neck of the vascular defect, and at least oneocclusive member connected to at least one securement member across awall of the stent, wherein the at least one occlusive member and the atleast one securement member are sized and shaped such that the at leastone occlusive member and the at least one securement member are securedto the stent with the at least one occlusive member located outside thestent interior region and the at least one securement member inside thestent interior region, wherein the at least one occlusive membercomprises an umbrella-like canopy, a parabola, or a sphereconfiguration, wherein the at least one occlusive member and the atleast one securement or both are formed from a swellable material or acompressed foam, and wherein the at least one securement member isconfigured to engage respective struts of the stent.